An Open Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of ANG-3777 Injected Intravenously in Stable Adult Maintenance Hemodialysis Subjects

The purpose of this study is to evaluate the pharmacokinetics and safety of a single-dose of ANG-3777 in subjects with renal failure receiving maintenance hemodialysis.

Start Date01 Jul 2021

Sponsor / Collaborator

Angion Biomedica Corp.

[+1]

NCT04898907 / Unknown statusPhase 1

A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects

The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.

Start Date01 Jun 2021

Sponsor / Collaborator

Angion Biomedica Corp.

[+1]

NCT04931524 / Unknown statusPhase 1

An Open Label, Single-Dose Study to Assess the Mass Balance Recovery, Metabolism and Excretion of [14C] ANG 3777 in Healthy Male Subjects

The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.

Start Date21 May 2021

Sponsor / Collaborator

Angion Biomedica Corp.

[+1]

100 Clinical Results associated with Refanalin

100 Translational Medicine associated with Refanalin

100 Patents (Medical) associated with Refanalin

Literatures (Medical) associated with Refanalin

01 Sep 2024·American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

The hepatocyte growth factor mimetic, ANG-3777, in kidney transplant recipients with delayed graft function: Results from a randomized phase 3 trial

Article

Author: Kim, Jim ; Aslam, Shakil ; Alperovich, Gabriela ; Vincenti, Flavio ; Faravardeh, Arman ; Bromberg, Jonathan ; Neylan, John ; Leca, Nicolae ; Csomor, Philipp Andreas

In kidney transplant recipients, delayed graft function increases the risk of graft failure and mortality. In a phase 3, randomized, double-blind, placebo-controlled trial, we investigated the hepatocyte growth factor mimetic, ANG-3777 (once daily for 3 consecutive days, starting ≤30 hours posttransplant), in 248 patients receiving a first kidney transplant from a deceased donor. At day 360, estimated glomerular filtration rate (primary endpoint) was not significantly different between the ANG-3777 and placebo groups. There were no significant between-group differences in the duration of dialysis through day 30 or in the percentage of patients with an estimated glomerular filtration rate of >30 mL/min/1.73 m² at day 360. The incidence of both delayed graft function and acute rejection was similar between ANG-3777 and placebo groups (68.5% vs 69.4% and 8.1% vs 6.5%, respectively). ANG-3777 was well tolerated, and there was a numerically lower incidence of graft failure versus placebo (3.2% vs 8.1%). Although there is insufficient evidence to support an indication of ANG-3777 for patients at risk of renal dysfunction after deceased-donor kidney transplantation, these findings indicate potential biological activity that may warrant further investigation.

22 Jun 2023·Journal of medicinal chemistryQ1 · MEDICINE

Discovery of Dimethyl Shikonin Oxime 5a, a Potent, Selective Bombesin Receptor Subtype-3 Agonist for the Treatment of Type 2 Diabetes Mellitus.

Q1 · MEDICINE

Article

Author: Wu, Lehao ; Li, Shaoshun ; Zhang, Yan ; Wang, Zeyuan ; Zhao, Chunxiao ; Xiao, Hua ; Cui, Jiahua ; Jia, Jinping ; Lu, Jihong

Bombesin receptor subtype-3 (BB₃, BRS-3) is an orphan G_αq protein-coupled receptor. The characterization of novel synthetic ligands for BB₃ is an alternative and attractive strategy to study its diverse physiological functions. Here, we uncovered the intimate pairing of DMAKO-00 and its derivatives with BB₃. Dimethyl shikonin oxime 5a (DSO-5a) was identified as the most potent agonist for BB₃ (pEC₅₀ = 8.422 in IP-1 accumulation), which was 898-fold more potent than DMAKO-00. Importantly, without brain penetration, DSO-5a improved glucose tolerance in C57BL/6 mice through BB₃ and ameliorated glucose homeostasis in diabetic db/db mice. We further revealed that DSO-5a upregulated PPAR-gamma activity via BB₃ through a quantitative proteomics approach. Collectively, our study demonstrated that DSO-5a, a representative compound of DMAKO-00 derivatives, is a potent, selective, and low-brain-penetrating agonist for BB₃, and BB₃ is a promising treatment target for type 2 diabetes mellitus.

01 Aug 2022·Environment international

New emerging polybromobiphenyls in serum of general population and their disruption on thyroid hormone receptor β1

Article

Author: Wang, Ying ; Jin, Hongli ; Bao, Junsong ; Jin, Jun ; Chen, Limei

After the PBBs pollution incident in Michigan, a large number of studies focused on the exposure of people to 2,2',4,4',5,5'-hexabromobiphenyl (BB-153), but paid less attention to other PBBs congeners in human serum. In this study, three monobromobiphenyls (BB-1, BB-2 and BB-3), five dibromobiphenyls (BB-4, BB-7, BB-9, BB-10 and BB-15), decabromobiphenyl (BB-209) and BB-153 in the serum of the general population in Wuxi from 2012 to 2016 were detected by GC-MS/MS. The most abundant congeners in serum samples were BB-1(median 254 ng·g^-1 lw), BB-10 (median 141 ng·g^-1 lw) and BB-209 (median 68.4 ng·g^-1 lw). The detection rate of BB-153 is less than 10%, and the concentration is far lower than that in other areas. The concentrations of BB-1, BB-10 and BB-209 are 3-4 orders of magnitude higher than the maximum concentration of BB-153. Serum concentrations of BB-209 increased significantly from 2012 to 2016 (p = 0.025). In addition, the concentrations of BB-1 in serum of females were significantly higher than that of males, and the concentrations of BB-1, BB-10 and BB-209 in serum of young adults were significantly higher than that of middle-aged adults. Finally, we found that BB-1 and BB-10 may have similar disruption on the binding of T3 and TRβ₁ as BB-153, while BB-209 has little effect on the binding of T3 and TRβ₁. This suggests that we should pay more attention to the damage of BB-1 and BB-10 to thyroid in the future.

News (Medical) associated with Refanalin

13 Nov 2023

·www.globenewswire.com

Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis

Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis Primary endpoint (negative culture and/or clear nail growth) met with 83.3% response rate Secondary endpoints met at Week 52 after 9-months off treatment Alderley Edge, 13 November 2023 Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical nanomedicines to treat dermatological conditions, announces that BB2603, a novel topical terbinafine antifungal product, has met the primary endpoint in the Phase 2b trial (BBTAF202) in patients with onychomycosis, showing superiority over placebo (vehicle) with a high level of statistical significance. BBTAF202 was a European trial conducted in 111 subjects with mild to moderate distal subungual onychomycosis (DSO) of the toenail, recruited from sites in Germany, Poland and the Czech Republic. This trial assessed the efficacy, safety and pharmacokinetics of 3 months twice-daily treatment of BB2603-10 versus vehicle, along with 2 lower formulation strengths of BB2603-3 and BB2603-1. A 3-month treatment duration is considerably shorter than for other topical agents used for onychomycosis (~11 months). The primary objective was an assessment of early clinical and/or mycological activity of BB2603-10 versus vehicle at Week 16, 1 month after end of treatment. Significantly more subjects treated with BB2603-10 (83.3%) had a response of negative dermatophyte culture and/or clear nail growth at Week 16 compared with those who received vehicle (51.8%, p=0.004). This treatment difference was driven by an early effect of BB2603-10 on negative culture (80.6% vs 40.5%, p<0.001). Growth of clear nail was observed in many subjects as early as Week 4. Clear nail and improvement in the appearance of fungally-infected toenail addresses an important aesthetic need of patients. Secondary endpoints were assessed at the end of the trial at Week 52, 9 months after the end of the 3-month treatment period. Even after this extended off-treatment period and the associated risk for mycological recurrence, 64% of patients treated with BB2603-10 had negative culture at Week 52, with 30.6% of patients achieving mycological cure (negative culture and negative microscopy) versus vehicle (5.4%, p=0.005). The safety and tolerability profile of BB2603 was excellent - there were no drug related adverse events (AEs), no application site reactions, no serious AEs and no AEs leading to treatment discontinuation with BB2603-10. The trial also confirmed no detectable systemic exposure following treatment with BB2603, meaning that there are no systemic safety concerns. Dr John Ridden, CEO of Blueberry Therapeutics, commented: "We are excited to announce the successful completion of our Phase 2b trial, which delivered remarkable treatment outcomes following just three months of dosing. Additionally, we are delighted by the exceptional safety observed throughout the study. We believe BB2603 can become a best-in-class topical treatment for onychomycosis. With a well-defined development roadmap in place, we are now in the planning stage for the forthcoming Phase 3 trials." Dr Juergen Dobmeyer, Chief Medical Officer of Blueberry Therapeutics, commented:"Onychomycosis is a notoriously difficult condition to treat with topicals often needing long treatment durations, which some patients struggle to maintain. These positive Phase 2 data with BB2603, which can be applied safely, easily and conveniently with a spray, show real promise." For more information about Blueberry Therapeutics please contact: Blueberry TherapeuticsDr Emma Leigh, Director of Communications info@blueberrytherapeutics.com ICR ConsiliumChris Welsh, Jessica Hodgson,blueberrytherapeutics@consilium-comms.com+44 (0)203 709 5700 About BB2603BB2603 is a topical antifungal spray formulation of the antifungal agent terbinafine for the treatment of onychomycosis. BB2603 uses our nano-delivery platform technology to enhance topical delivery through the nail to the site of infection, in an easy-to-use spray. This affords the opportunity to use lower doses and shorter treatment durations than other topical treatments, and to match the cure rates of the more effective oral formulations, without the associated safety concerns. In a previous Phase 1/2 trial (BBT120126032001) conducted in patients with onychomycosis and associated tinea pedis, BB2603 was shown to be safe and well-tolerated, with no systemic exposure, and preliminary evidence of antifungal effects. On the back of these positive Phase 2b data from BBTAF202, Phase 3 development of BB2603 is now underway. About Blueberry Therapeutics Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value nanomedicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life. Blueberry applies innovative formulation technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic dermatitis (eczema). For more information visit: blueberrytherapeutics.com

Clinical ResultPhase 2Phase 3

17 Jan 2023

·medcitynews.com

Cancer Biotech Elicio Finds Path to Public Markets Via Angion Reverse Merger

Cancer immunotherapy developer Elicio Therapeutics is finally getting a listing on the public markets to finance its clinical research. But rather than the traditional IPO it had been seeking, the biotech is going public via a reverse merger with ailing Angion Biomedica. Under terms of the merger deal announced Tuesday, Elicio shareholders will own about 65.5% of the combined company, which will operate under the Elicio name. The deal comes as Elicio continues clinical development of lead program ELI-002, which is in development for treating cancers characterized by the difficult-to-target mutation called KRAS. A Phase 1 dose-escalation study has completed enrollment at the final dose level. Boston-based Elicio expects to begin an additional Phase 1/b2 trial in the second half of this year. Elicio develops drugs using proprietary technology that delivers immunotherapies to the lymph nodes, which contain large numbers of immune cells. By applying this technology to therapies that aren’t predisposed to getting into the lymph nodes, the company believes it can enhance their uptake by these organs and their action on important immune cells. This technology platform, which comes from the Massachusetts Institute of Technology, was used to develop ELI-002. This experimental cancer vaccine is intended to generates an immune response to KRAS peptide antigens modified by Elicio’s technology. ELI-002 also includes an adjuvant to boost the immune response. This adjuvant has been developed with the company’s proprietary technology. Elicio initially filed to go public in 2021 as it looked ahead to clinical testing of ELI-002. The clinical trial began, but the IPO never happened. The Phase 1/2 study is evaluating the Elicio cancer vaccine in patients with solid tumors, including colorectal cancer and pancreatic ductal adenocarcinoma. According to Elicio’s regulatory filings, the study is designed to target patients with minimal residual disease, a stage where the number of tumors and the immunosuppressive effects within the tumors are reduced. Last September, Elicio notified the Securities and Exchange Commission that it was withdrawing its IPO paperwork, but leaving the door open to an IPO possibility. The company chose a reverse merger instead. “We believe this merger reflects the strength of the ELI-002 program, our pipeline, and the value-creating potential of our lymph node-targeting approach to treating cancer and other diseases by engaging lymph nodes, the ‘schoolhouse’ of the immune system,” Elicio CEO Robert Connelly said in a prepared statement. The kidneys were the focus Angion. Lead program ANG-3777 was in development for treating acute kidney injury. However, Phase 3 testing yielded results that the company concluded would not support approval in kidney transplant patients at risk for delayed graft function. After a separate Phase 2 test in acute kidney injury associated with cardiopulmonary bypass surgery, the company concluded the data would not support advancing to Phase 3 testing. Last January, Angion laid off nearly half of its workforce. In July, the company announced it would explore strategic options that include a merger, reverse merger, or sale of its assets. With the execution of the merger agreement, Angion committed up to $10 million in a bridge loan to Elicio. The combined company will be led by Elicio’s management team and Elicio will remain headquartered in Boston. Angion President and CEO Jay Venkatesan will have a seat on the combined company’s board of directors. The boards of both companies have approved the merger, which is expected to close in the second quarter of this year. When it does, the new Elicio expects to trade on the Nasdaq under the stock symbol “ELTX.” Public domain image by the National Cancer Institute

VaccineAcquisitionClinical ResultIPOImmunotherapy

26 Jul 2022

·endpts.com

Following a host of trial flops, Angion halts R&D work, searches for ‘strategic alternatives’

After scrapping a Phase II kidney disease study last month, it appears Angion Biomedica may be out of moves. The Uniondale, NY-based biotech announced Monday afternoon that it would be looking into “strategic alternatives” — suggesting a potential merger, reverse merger and sale or licensing of its candidates as options it would be exploring. In the meantime, Angion will be shuttering its R&D work. “In order to preserve as much of the over $60 million in cash and cash equivalents in place at the end of the second quarter, we are discontinuing development of ANG-3070 for all indications and discontinuing most other development activities pending conclusion of this process, plus taking other actions to immediately reduce cash burn to better position the company for this strategic alternatives process,” Angion president and CEO Jay Venkatesan said in a press release . ANG-3070 was pushed to the front of Angion’s pipeline as its lead candidate faced one trial fail after another. In July of last year, ANG-3777 missed in a Phase II study for Covid-19. Then not long after, the drug flunked two separate kidney studies, leading Angion to pivot to ANG-3070. However, ANG-3070, a TKI inhibitor, didn’t pan out either. Angion shelved a Phase II study of the drug in kidney diseases after one patient reportedly had “unexpected and substantial decline” in their kidney function. In premarket trading, $ANGN was down 5%, floating around the $1 mark.

Acquisition

100 Deals associated with Refanalin

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Delayed Graft Function	Phase 3	US	Angion Biomedica Corp.	01 Mar 2016
Functional disorder	Phase 3	US	Angion Biomedica Corp.	01 Mar 2016
COVID-19	Phase 2	BR	Angion Biomedica Corp.	31 Jul 2020
Acute Kidney Injury	Phase 2	US	Angion Biomedica Corp.	24 Feb 2017
Acute Kidney Injury	Phase 2	BR	Angion Biomedica Corp.	24 Feb 2017
Acute Kidney Injury	Phase 2	CA	Angion Biomedica Corp.	24 Feb 2017
Acute Kidney Injury	Phase 2	GE	Angion Biomedica Corp.	24 Feb 2017
ST Elevation Myocardial Infarction	Phase 2	US	Angion Biomedica Corp.	01 Jul 2012
Death, Sudden, Cardiac	Phase 2	NL	Angion Biomedica Corp.	01 Aug 2011
Death, Sudden, Cardiac	Phase 2	ES	Angion Biomedica Corp.	01 Aug 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02474667 (Pubmed) Manual	Phase 3	Delayed Graft Function	248	ANG-3777	ugyyccjcai(vsliksltys) = not significantly different between the ANG-3777 and placebo groups. sngpbrwdck (nnaabvwpmd )	Negative	20 Feb 2024
				Placebo
NCT02771509 (GUARD, GlobeNewswire) Manual	Phase 2	Acute Kidney Injury	275	Refanalin	ypgzzwyred(mpqzzrfxmx) = vdcdamxldf loqwsbfjxe (qfjlwnzjdw ) View more	Negative	09 Dec 2021
				Placebo	ypgzzwyred(mpqzzrfxmx) = mtyuklbtyd loqwsbfjxe (qfjlwnzjdw ) View more
NCT02474667 (GlobeNewswire) Manual	Phase 3	Renal transplant rejection	253	Refanalin	tmwiivcbdy(zcrjasgmup) = fbprqamoqu dbfzovrfad (kqgeqhqred )	Negative	26 Oct 2021
				Placebo	tmwiivcbdy(zcrjasgmup) = ttgumwibha dbfzovrfad (kqgeqhqred )
NCT01286727 (Pubmed) Manual	Phase 2	Renal transplant rejection	28	Refanalin	cguqlarunf(tmcgsohreo) = rsjzikbgvt konsjoidzn (pgbzqriqok )	Positive	01 Feb 2021
				Refanalin	cguqlarunf(tmcgsohreo) = qtckvrdkfq konsjoidzn (pgbzqriqok )
Phase 2 study (ASN2020)	Phase 2	Neoplasms c-MET	-	ANG-3777 2 mg/kg	ouikveezpw(htsilhxoon) = Overall survival did not differ in animals treated with ANG-3777 vs vehicle ozcdhegtkx (aziugalykq ) View more	Positive	19 Oct 2020
				Vehicle (dimethyl sulfoxide)
GUARD study in AKI patients and Phase 3 GIFT study in kidney Tx recipients (ASN2015)	Phase 2/3	Reperfusion Injury	-	BB3 2 mg/kg	jddypqhcqj(zntjolpbqv) = devikozesu oupfvktani (vejjyvdypf ) View more	Positive	03 Nov 2015
				BB3	jddypqhcqj(zntjolpbqv) = gebavteyuw oupfvktani (vejjyvdypf )
Phase 2 study (ASN2015)	Phase 2	Delayed renal graft function	-	BB3 (2 mg/kg IV QD X 3 d)	yzgrilnldr(peolukpdqf) = subnvfsery eacadtwnfo (qhwuypmbum )	Positive	03 Nov 2015
				Placebo	yzgrilnldr(peolukpdqf) = clftpdjyug eacadtwnfo (qhwuypmbum )

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